Coronary Heart Disease (CHD)NCT07074834
Metoprolol and Trimetazidine for Coronary Heart Disease With Angina
A study testing Metoprolol Succinate Sustained-Release Tablets, Trimetazidine and Routine Drug Therapy in people with Coronary Heart Disease (CHD), run by Shiyan City Renmin Hospital at 1 site in China.
Trial summary
This is a prospective, randomized study to evaluate the effectiveness and safety of combining metoprolol succinate with trimetazidine compared to standard therapy for patients with coronary heart disease (CHD) and angina pectoris. Read more about this study
- Who is it for?
- Ages 46 to 76 years
- Conditions the study is for
- Coronary Heart Disease (CHD)
- What is being tested?
- Metoprolol Succinate Sustained-Release Tablets, Trimetazidine and Routine Drug Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 46 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of CHD and angina pectoris based on CAD and angina pectoris guidelines.
- History of previous myocardial infarction, confirmed by coronary angiography or coronary computed tomography angiography, with at least one coronary artery stenosis ≥50%.
- Disease duration over 3 months.
- Frequency of angina attacks in the past week was ≥3 times, with a severity grade of I, II, or III.
- All patients signed an informed consent form.
Who cannot join
- Patients with mental disorders, drug allergies, acute myocardial infarction, electrolyte imbalances, important organ dysfunction, or cardiomyopathy.
- Patients with severe immune or infectious diseases.
- Those with stable symptoms or no symptoms after acute coronary syndrome.
- Patients with severe arrhythmia, uncontrolled hypertension (SBP ≥180 mmHg or DBP ≥110 mmHg), pacemaker, or aortic dissection.
- Pregnant or lactating women.
- Patients requiring revascularization (e.g., multi-vessel disease, left main disease, or ischemic areas >10% of the left ventricle).
- Patients who participated in other clinical trials within the past month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Metoprolol Succinate Combined With Trimetazidine in Reducing Inflammatory Biomarkers and Improving Clinical Outcomes in Coronary Heart Disease With Angina Pectoris
This is a prospective, randomized study to evaluate the effectiveness and safety of combining metoprolol succinate with trimetazidine compared to standard therapy for patients with coronary heart disease (CHD) and angina pectoris. The study aims to assess the effects of the combination therapy on inflammatory biomarkers, clinical efficacy, angina symptoms, and left ventricular function over a 3-month treatment-period.
Read the detailed description
Coronary heart disease (CHD) with angina pectoris is a significant cause of morbidity and mortality. While standard treatments like β-blockers (e.g., metoprolol succinate) are effective, many patients continue to experience symptoms. Inflammation is known to play a crucial role in the pathophysiology of CHD. This study was designed to investigate whether the addition of trimetazidine, a myocardial anti-ischemic agent that improves cellular energy metabolism, to standard metoprolol succinate therapy could offer superior benefits. This prospective study enrolled and randomized 102 patients with CHD and angina into two groups: a control group receiving routine drug therapy and a treatment group receiving routine therapy plus metoprolol succinate and trimetazidine. The primary objective was to compare the therapeutic efficacy, changes in angina attack frequency and severity, improvements in left ventricular function, and reductions in key inflammatory markers (IL-1β, TNF-α, hs-CRP, IL-18) between the two groups after 3 months of treatment. The study aims to provide evidence for this combination therapy as a safe and effective option for managing CHD with angina pectoris.
- Conditions
- Coronary Heart Disease (CHD)
- Being tested
- Metoprolol Succinate Sustained-Release Tablets, Trimetazidine, Routine Drug Therapy
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metoprolol Succinate Sustained-Release TabletsDrug
Oral administration. Dose was 23.75 mg once daily for the first two weeks, then increased to 47.50 mg once daily.
TrimetazidineDrug
Oral administration. Dose was one tablet twice daily.
Routine Drug TherapyDrug
Included oral nitroglycerin tablets (0.5 mg twice daily), aspirin enteric-coated tablets (0.1 g once daily), and rosuvastatin calcium tablets (10 mg three times daily).
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Treatment Group | Experimental | Patients were randomized to receive routine drug therapy plus metoprolol succinate combined with trimetazidine for 3 months. Receives: Drug: Metoprolol Succinate Sustained-Release Tablets; Drug: Trimetazidine; Drug: Routine Drug Therapy |
| Active Comparator: Control Group | Active comparator | Patients were randomized to receive routine drug therapy for 3 months. Receives: Drug: Routine Drug Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Efficacy Rate
Clinical efficacy was assessed based on symptom changes and reduction in angina attacks. Efficacy was categorized as "Marked effect" (symptoms nearly controlled, attacks decreased >80%), "Effective" (symptoms partially improved, attacks decreased 50-80%), or "Ineffective". The total effective rate was calculated as (Marked effect + Effective) / Total cases × 100%.
Measured: At 3 months
Change in Frequency of Angina Attacks
The mean number of angina attacks per week was recorded and compared between groups.
Measured: From Baseline to 3 months
Change in Serum Inflammatory Markers
Changes in serum levels of Interleukin-1 beta (IL-1β), Tumor Necrosis Factor-alpha (TNF-α), and high-sensitivity C-reactive protein (hs-CRP) were measured using ELISA and immune transmission nephelometry.
Measured: From Baseline to 3 months
Secondary outcomes (7)
Change in Angina Pain Score
Pain severity was assessed using the Visual Analog Scale (VAS) with a score from 0 (no pain) to 10 (most severe pain).
Measured: From Baseline to 3 months
Change in Duration of Angina Episodes
The mean duration of angina attacks was recorded and compared.
Measured: From Baseline to 3 months
Change in Left Ventricular Ejection Fraction (LVEF)
LVEF was measured by color Doppler ultrasound to assess left ventricular systolic function.
Measured: From Baseline to 3 months
Change in Left Ventricular End-Diastolic Diameter (LVEDD)
LVEDD was measured by color Doppler ultrasound to assess cardiac remodeling.
Measured: From Baseline to 3 months
Change in Left Ventricular End-Systolic Diameter (LVESD)
LVESD was measured by color Doppler ultrasound to assess cardiac remodeling.
Measured: From Baseline to 3 months
Change in Serum Interleukin-18 (IL-18) levels
Serum IL-18 levels were measured using ELISA.
Measured: From Baseline to 3 months
Incidence of Adverse Reactions
The number and percentage of patients experiencing adverse reactions, including gastrointestinal abnormalities, arrhythmias, or hypotension, were recorded.
Measured: Over 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Feb 2021
- Primary completion30 Sep 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart Disease (CHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiyan City Renmin Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Qunxiong Fan, Shiyan City Renmin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074834
- Sponsor's protocol ID
- syrmyy2020-068
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Metoprolol Succinate Combined With Trimetazidine in Reducing Inflammatory Biomarkers and Improving Clinical Outcomes in Coronary Heart Disease With Angina Pectoris
- ClinicalTrials.gov ID
- NCT07074834
- Acronym / sponsor ID
- syrmyy2020-068
- Conditions
- Coronary Heart Disease (CHD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Shiyan City Renmin HospitalOther government
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized study to evaluate the effectiveness and safety of combining metoprolol succinate with trimetazidine compared to standard therapy for patients with coronary heart disease (CHD) and angina pectoris. The study aims to assess the effects of the combination therapy on inflammatory biomarkers, clinical efficacy, angina symptoms, and left ventricular function over a 3-month treatment-period.
Detailed description
Coronary heart disease (CHD) with angina pectoris is a significant cause of morbidity and mortality. While standard treatments like β-blockers (e.g., metoprolol succinate) are effective, many patients continue to experience symptoms. Inflammation is known to play a crucial role in the pathophysiology of CHD. This study was designed to investigate whether the addition of trimetazidine, a myocardial anti-ischemic agent that improves cellular energy metabolism, to standard metoprolol succinate therapy could offer superior benefits. This prospective study enrolled and randomized 102 patients with CHD and angina into two groups: a control group receiving routine drug therapy and a treatment group receiving routine therapy plus metoprolol succinate and trimetazidine. The primary objective was to compare the therapeutic efficacy, changes in angina attack frequency and severity, improvements in left ventricular function, and reductions in key inflammatory markers (IL-1β, TNF-α, hs-CRP, IL-18) between the two groups after 3 months of treatment. The study aims to provide evidence for this combination therapy as a safe and effective option for managing CHD with angina pectoris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Treatment Group | Experimental | Drug: Metoprolol Succinate Sustained-Release Tablets, Drug: Trimetazidine, Drug: Routine Drug TherapyPatients were randomized to receive routine drug therapy plus metoprolol succinate combined with trimetazidine for 3 months. |
| Active Comparator: Control Group | Active comparator | Drug: Routine Drug TherapyPatients were randomized to receive routine drug therapy for 3 months. |
Who may qualify
- Ages
- 46 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of CHD and angina pectoris based on CAD and angina pectoris guidelines.
- History of previous myocardial infarction, confirmed by coronary angiography or coronary computed tomography angiography, with at least one coronary artery stenosis ≥50%.
- Disease duration over 3 months.
- Frequency of angina attacks in the past week was ≥3 times, with a severity grade of I, II, or III.
- All patients signed an informed consent form.
Key exclusion criteria (7 listed)
- Patients with mental disorders, drug allergies, acute myocardial infarction, electrolyte imbalances, important organ dysfunction, or cardiomyopathy.
- Patients with severe immune or infectious diseases.
- Those with stable symptoms or no symptoms after acute coronary syndrome.
- Patients with severe arrhythmia, uncontrolled hypertension (SBP ≥180 mmHg or DBP ≥110 mmHg), pacemaker, or aortic dissection.
- Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metoprolol Succinate Sustained-Release TabletsOral administration. Dose was 23.75 mg once daily for the first two weeks, then increased to 47.50 mg once daily. | Drug | Experimental: Treatment Group |
| TrimetazidineOral administration. Dose was one tablet twice daily. | Drug | Experimental: Treatment Group |
| Routine Drug TherapyIncluded oral nitroglycerin tablets (0.5 mg twice daily), aspirin enteric-coated tablets (0.1 g once daily), and rosuvastatin calcium tablets (10 mg three times daily). | Drug | Active Comparator: Control Group, Experimental: Treatment Group |
Primary outcome
Change in Clinical Efficacy Rate
Time frame: At 3 months
Clinical efficacy was assessed based on symptom changes and reduction in angina attacks. Efficacy was categorized as "Marked effect" (symptoms nearly controlled, attacks decreased >80%), "Effective" (symptoms partially improved, attacks decreased 50-80%), or "Ineffective". The total effective rate was calculated as (Marked effect + Effective) / Total cases × 100%.
Change in Frequency of Angina Attacks
Time frame: From Baseline to 3 months
The mean number of angina attacks per week was recorded and compared between groups.
Change in Serum Inflammatory Markers
Time frame: From Baseline to 3 months
Changes in serum levels of Interleukin-1 beta (IL-1β), Tumor Necrosis Factor-alpha (TNF-α), and high-sensitivity C-reactive protein (hs-CRP) were measured using ELISA and immune transmission nephelometry.
7 secondary outcomes
Change in Angina Pain Score
Time frame: From Baseline to 3 months
Change in Duration of Angina Episodes
Time frame: From Baseline to 3 months
Change in Left Ventricular Ejection Fraction (LVEF)
Time frame: From Baseline to 3 months
Change in Left Ventricular End-Diastolic Diameter (LVEDD)
Time frame: From Baseline to 3 months
Change in Left Ventricular End-Systolic Diameter (LVESD)
Time frame: From Baseline to 3 months
Change in Serum Interleukin-18 (IL-18) levels
Time frame: From Baseline to 3 months
Incidence of Adverse Reactions
Time frame: Over 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metoprolol Succinate Sustained-Release Tablets, Trimetazidine and Routine Drug Therapy in people with Coronary Heart Disease (CHD), run by Shiyan City Renmin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical Efficacy Rate (time frame: At 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.